Study Title:    Individualised assessment and management of mild traumatic brain injury: widening access to resources for recovery (I am brain aware)

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We would like to invite you to take part in a research study.  It is important that you understand why the project is being carried out and what will be involved.  This information sheet will help you decide whether to take part.  Please discuss it with your family or General Practitioner if you wish. If you have any questions, please contact us using the details provided at the end of this sheet.  Your participation is entirely voluntary.

1. What is the purpose of the study?
•    In the United Kingdom more than 1 million people attend emergency departments (ED) annually with a traumatic brain injury (TBI), of which the majority (between 80 and 90 percent) are classified as mild. “Mild” TBI should not be underestimated; more than 30percent of patients discharged with this diagnosis experience significant, life-changing problems that can last months to years.
•    Currently the majority of patients are sent home with advice and no planned follow-up. There is an expectation that patients with persisting problems will seek help themselves. However, the nature of mild TBI (mTBI) makes this difficult, and often patients struggle to access the care they need. This is an unmet healthcare need affecting millions of individuals worldwide each year.
•    In this study we want to hold Focus Groups with people who have experienced a mTBI, their carers and healthcare professionals who support people with mTBI. During these focus groups we want to explore people’s experiences and perspectives on mTBI are and discuss what patient reported outcome measures (questionnaires about you/your health) are essential to measure. We also want to discover what you thought of your hospital experience (treatment and discharge) and after care.
•    The results of the Focus Groups will be used to help develop an application (app) called “I Am Brain Aware”. An app is a software program that's designed to perform a specific function directly for the user. The aim of this app would be to help mTBI patients post hospital discharge with any problems they may experience and offer support for these problems.

2. Why have I been invited?
You have been invited to take part as you fall into one of the three main groups of participants that we would like to recruit for this study: 1) people who have experienced mTBI; 2) relatives/carers of people who have experienced mTBI; 3) healthcare professional who supports people who have sustained an mTBI.

3. Do I have to take part?
No. It is up to you to decide whether or not to take part.  If you decide to take part and then change your mind you may withdraw at any time without giving a reason. Your decision about whether to take part will not affect your treatment or that of the person you are caring for. 

4. What will I need to do if I take part?
We will invite you to take part in a Focus Group with one or more of our researches in a location convenient to the majority of the participants or on an online meeting platform (such as Zoom or Teams meeting). During the focus group, researchers will ask you questions about your experiences of mTBI and you will be encouraged to discuss these with the other people also in attendance. The Focus Group will be audio recorded on a digital voice recorder (Dictaphone).  Afterwards, the recording will be transcribed (typed out) by a transcription service (The Typing Works) and analysed by the research team. Participants can pause, rewind and/or delete any section of the audio recorded interview should they wish to.  The Focus Group discussions may last up to 3 hours.

The anonymised transcribed interviews will be stored securely on password protected computers for the duration of the project and this data will only be accessible by the research team.  After 10 years the data will be securely disposed of.

To compensate you for your time and participation, you will receive payment of £25.00 per hour of your time; the Focus Group discussions may last up to 3 hours.  Any cost that arises from transport to attend the interview will be refunded by the University of Cambridge.  Reimbursement for your time and travel expenses will not prejudice the healthcare you receive.

5. What are the benefits of taking part in this study?
There is no guarantee that you will benefit personally from taking part. Although some people have reported a “therapeutic feeling” when given the opportunity to verbalise their feelings and needs with other health-care professionals/researchers. Possible long-term benefits of this research are that it will help to improve the care of patients with mTBI and also help to support their carers. Your contribution will be valuable in helping us achieve this. If during the interview a serious health or social care need is revealed, the researcher will ask your permission to act on this by referring you to the appropriate service.

6. Are there any risks?
We do not believe you will be harmed in any way by participating in this research.  This study does not involve testing a drug or medical procedures. 

7. How will the findings be used?
The results will be used to develop an app that will help identify mTBI patients that are experiencing poor 

outcomes and offer early interventions and access to on-going care. The research will be reported in a way that is confidential and your participation will not be identified in any way. The results may be published on the study website and in healthcare journals, presented at conferences and to patient support groups. If you would like to be kept informed of the results, please tell the researcher or contact the study team using the details on the last page.

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8. Will my taking part in this study be kept confidential?
Cambridge University Hospitals NHS Foundation Trust (CUH) and The University of Cambridge are the Sponsors for this research study based in the United Kingdom. They will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that they are responsible for looking after your information and using it properly. The Sponsor organisations will keep identifiable information about you for 10 years after the study has finished to ensure your safety and allow the study to be reviewed by the authorities after it is finished. 
 
Your rights to access, change or move your information are limited, as the Sponsor organisations need to manage your information in specific ways in order for the research to be reliable and accurate. To safeguard your rights, we will use the minimum personally-identifiable information possible.

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You can find out more about how the Sponsors use your information using the information below:

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- For Cambridge University Hospitals NHS Foundation Trust, please visit: https://www.cuh.nhs.uk/corporate-information/about-us/our-responsibilities/looking-after-your-information, or email the Data Protection Officer at: cuh.gdpr@nhs.net  

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- For University of Cambridge, please visit:
https://www.medschl.cam.ac.uk/research/information-governance/, or email 
the Information Governance team at: researchgovernance@medschl.cam.ac.uk

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Cambridge University Hospitals will collect your name, hospital number and contact details to contact you about this study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from the Sponsors and regulatory organisations may look at your medical and research records to check the accuracy of this study. Cambridge University Hospitals will pass these details to the Sponsors along with the information collected from you. The only people in the Sponsor organisations who will have access to information that identifies you will be people who need to contact you in relation to this study and to audit the data collection process. Cambridge University Hospitals will keep identifiable information about you from this study for 10 years after the study has finished.

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All information collected about you as a result of your participation in the study will be kept strictly confidential.  Your personal and medical information will be kept in a secured file and be treated in the strictest confidence.  

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Once you have agreed to participate in this study you will be allocated a Study ID (Identification) Number.  This is a unique study number which will be used on all your study documentation along with your date of birth. Your date of birth is considered to be personal information. We collect this personal information on study documentation to help ensure that the data we receive as part of your study participation is correctly allocated to you.  By cross checking these two unique references we can ensure the integrity of the data. 

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The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details.  Only anonymous study data, without any personal information will be published at the end of the study.

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Data collected as part of this study may be shared in an anonymised form with other biomedical researchers (academic or commercial) conducting ethically approved studies, including those from non-European Union countries involved in medical research.  In addition, when appropriate, data generated by the study will be analysed by commercial collaborators (such as those involved in developing new medicines or diagnostic devices), based either in the United Kingdom or overseas.  All such analyses will be undertaken only on de-identified data with all link tables retained by the study team.  Identifiable data will not be passed to external teams. Data will be held in secure storage and destroyed after ten years. Any information that you give will be used for research purposes only and you may ask to see your personal information at any time. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research.

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This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.

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9. Can I withdraw from the project?
Yes. You may withdraw from the study at any time without giving a reason. This will not affect your treatment or care, or the care or treatment of the person you are caring for. If you withdraw we will ask your permission to retain and use any personal information you have provided up to that point. We will remind you of your right to withdraw at regular intervals and will provide withdrawal options (including complete removal and destruction of your data) should you decide you no longer wish to take part. If you become unwell during the study to the extent that you are no longer able to provide consent, we will withdraw you from the study and we will retain the identifiable data and information you have provided up to that point.

10. What if there is a problem or I want to make a complaint?
If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions. If you wish to speak to somebody who is independent you can contact Cambridge University Hospital’s Patient Advice and Liaison Service (PALS):

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Address    Box 53, Cambridge University Hospitals, Cambridge Biomedical Campus, Hills Road, Cambridge, CB2 0QQ
Phone    01223 216756 (Monday to Friday: 9am to 4pm)
Email    cuh.pals@nhs.net

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11. Who has organised the research?
The Chief Investigator for the study is Dr Virginia Newcombe, Department of Medicine, University of Cambridge, who is working with researchers from the University of Cambridge, University of Sheffield and University of Stirling. The sponsors for the research are Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge.

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12. How has this study been reviewed?
Before funding for the study was awarded it was reviewed. It has also been reviewed by external researchers and several public representatives, and the investigators made changes to improve the study. The study has been independently reviewed and approved by Cambridge University Hospitals Research Committee (RAC).  The study and all documents have also undergone ethical review by the North of Scotland (1) Research Ethics Service. This is necessary before any study can be conducted. 
13. How has this study been funded?
The research is funded by the National Institute for Health Research Advanced Fellowship (award reference NIHR 302544). 
 

13. How has this study been funded?

The research is funded by the National Institute for Health Research Advanced Fellowship (award reference NIHR 302544).

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14. Further information and contact details

If you would like more information at any time during or after your participation in the study, please contact Dr Virginia Newcombe or Anne Manktelow with the details below:

 

I Am Brain Aware Research Team

Office:01223 596148

Mobile: 07845 229971

Email: tbicambridge@gmail.com

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15. How to get involved

If you are interested in participating in this study, please complete and submit the Contact Form* in the tab above and we will contact you to arrange a appointment to suit you.  Thank you!

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